Jewish Chronic Disease Hospital

Comments (0)

Transcript of Jewish Chronic Disease Hospital

Violations of the Belmont ReportPrecautions TakenHarvard Medical School professor Henry K. Beecher published an expose` of unethical research in The Journal in 1966.

JCDH was among 22 cases cited in the Beecher Report.

Beecher's report merely asked investigators to be more conscientious in obtaining informed consent.

Along with many other reported biomedical abuses, JCDH case contributed to Congress passing the National Research Act in 1974.

National Research Act established the National Commission for the Protection of Human Subjects of Biomedical Behavioral Research. Overview1963 study conducted by New York's Jewish Chronic Disease Hospital

Aim was to understand whether the body's inability to reject cancer cells was due to cancer or debilitation

It was thought that debilitated patients would also reject the cancer cells, just more slowly... and so began the JCDH studyWho was Involved?BeneficenceThe philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects

The subjects of this study received no benefit from their participation.

The investigators had no proof that subjects would not develop cancer.

No review committee and no approval was sought from attendees providing patient care.Respect for PersonsProtecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception

No informed consent from individuals of diminished autonomy

Subjects were not given adequate information and could not voluntarily enter/leave the study.

Elderly (vulnerable) adults with impaired mental capacity who could not give voluntary consent

Study subjects were deceived about the nature of the cells being injectedAdditional Violations by Southam1954 Southam injected leukemia patients with HeLa cells to see if tumors would grow. 4 patients has recurring nodules1 patient the cancer metastasized

He had also performed the cancer-cell experiments on 65 healthy prisoners at an Ohio state penitentiary.ResourcesJanel PhetteplaceSam FreezeMarch 7th, 2014

JusticeEnsuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.

The subject population of this study should not have been exploited as they were a vulnerable population (many with dementia and all with debilitating chronic diseases).

Many of the patients only spoke Yiddish limiting effective communication.

Guardians were not asked for permission.

Consent was deceptive, inadequate and not translated.

Violation RisksInjected foreign, live cancer cells into 22 senile patients who were hospitalized for various chronic diseasesPatients were not told they would be injected with cancer cellsThought that disclosure would "unnecessarily frighten the patients"Predicted that "cancer cells would be rejected"Decided to avoid the "phobia and ignorance that surrounds the word cancer" by telling patients "they were getting human cells growing in test tubes."Of note, the Nuremberg Code had already been passed in 1947 which defined "legitimate medical research" in response to Nazi research crimes against human subjects.The study was financed by the United States Public Health Service, National Institutes of Health and the American Cancer Society

Dr Chester Southam, a noted immunologist at Sloan-Kettering Hospital

Three additional resident physicians were approached to perform the injections and all resigned in objection to the research.

Southam was not ostracized by his peers. In fact, he was elected as the president of the American Association for Cancer Research a few years later in 1968 and was elected VP of the American Cancer Society in 1967 .ViolationAccording to Southam, there was "no risk" to the patients.

Bernard Pisani, past president of the Medical Society of the County of New York, testified before the New York Supreme Court that... "the known hazards of such experiments include the growth of nodules and tumors and may result in metastasis if the cells are not rejected."

During the study, tumors grew within hours of injection.

In most patients, tumors were removed or vanished. Cancer metastasized in one patient. Legal ActionWilliam Hyman, a member of the JCDH Board of Directors, asked to review patient medical records and was refused by Dr. Mandel. Led to a lawsuit that alerted the media.

Following the lawsuit there was a hearing in front of the Board of Regents of the University of the State of NY led by NY State Attorney General Louis Lefkowitz

Initially, Drs. Southam and Mandel were found guilty of fraud, deceit, and unprofessional conduct. The board voted to suspend their medical licenses for a year. This was ultimately lessened to one year probation. 1. Katz, J. Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions and State in the Human Experimentation Process. The Russell Sage Foundation. Yale University. 1972

2. Lerner, B. Sins of Omission-Cancer Research without Informed Consent. The New England Journal of Medicine. 315:7. 2004.